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Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411086
First Posted: December 13, 2006
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Results First Submitted: November 3, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Biological: Rituximab
Biological: Sargramostim (GM-CSF)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: December 2006 and May 2009. All recruitment was done in medical clinics in participating Community Clinical Oncology Program sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rituximab + GM-CSF Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.

Participant Flow:   Overall Study
    Rituximab + GM-CSF
STARTED   52 
COMPLETED   52 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rituximab + GM-CSF Rituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.

Baseline Measures
   Rituximab + GM-CSF 
Overall Participants Analyzed 
[Units: Participants]
 52 
Age 
[Units: Years]
Median (Full Range)
 57 
 (31 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      24  46.2% 
Male      28  53.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   1.9% 
Not Hispanic or Latino      51  98.1% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      49  94.2% 
More than one race      0   0.0% 
Unknown or Not Reported      3   5.8% 
Region of Enrollment 
[Units: Participants]
 
United States   52 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Response Rate   [ Time Frame: 12 weeks (3 months) ]

2.  Secondary:   Median Progression-Free Survival (PFS)   [ Time Frame: 3 years ]

3.  Secondary:   Overall Response (OR) Rate   [ Time Frame: 3 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Clinical Research Operations Team, Office of VP Clinical Research
Organization: UT MD Anderson Cancer Center
phone: 713-792-7734
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00411086     History of Changes
Obsolete Identifiers: NCT00409474
Other Study ID Numbers: MDA-2006-0260
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-2006-0260 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000521620 ( Registry Identifier: NCI PDQ )
NCI-2009-00187 ( Registry Identifier: NCI CTRP )
First Submitted: December 11, 2006
First Posted: December 13, 2006
Results First Submitted: November 3, 2017
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017